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Important Safety Information

What is the most important information I should know about octreotide acetate for injectable suspension?

Treatment with octreotide acetate for injectable suspension may affect gallbladder function, with reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; stool discoloration and loose stool, which may require monitoring by your doctor. Tell your doctor if you experience signs or symptoms of gallstones or any of their complications.

Patients with carcinoid tumors and VIP-secreting tumors should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. 

Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.

What should I tell my doctor before taking octreotide acetate for injectable suspension?

Tell your doctor if you have a history of heart disease or are taking other medications, including cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.

What are the possible side effects of octreotide acetate for injectable suspension?

In acromegalic patients, the most common side effects of octreotide acetate for injectable suspension include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, gallstones, high blood pressure, dizziness and fatigue.

In carcinoid tumor and VIP-secreting tumor patients, the most common side effects of octreotide acetate for injectable suspension include back pain, fatigue, headache, abdominal pain, nausea, and dizziness.

These are not all of the possible side effects of octreotide acetate for injectable suspension. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is octreotide acetate for injectable suspension?

Octreotide acetate for injectable suspension is a prescription medication used in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated for:

• Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal.
• Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
• Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

In patients with carcinoid tumors and VIP-secreting tumors, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined.

Please see the full Prescribing Information.